Dysthymia: Associated Costs, Treatment and Change Process
DFront
DepressionForefront: Costs, Treatment and Change Process for Dysthymia
1 other identifier
interventional
80
1 country
1
Brief Summary
The study evaluates cost and effect of inpatient versus outpatient treatment of dysthymia, as well as investigates the processes through which psychotherapy works in treating dysthymia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Jan 2016
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJune 3, 2021
May 1, 2021
5.9 years
May 15, 2017
May 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Depressive symptoms
Beck depression inventory
At assessment, start (12 weeks after assessment) and end (24 weeks after assessment) of therapy, and at one-year follow up (76 weeks after assessment).
Change in Depressive symptoms
Patient health questionnaire
Once every week for the 12 weeks of active psychotherapy
Change in Cost of living with dysthymia
cost of living with dysthymia, cost-effectiveness of therapy at one-year and at 10 years. Information will be gathered from various registries and combined to a sum of money.
pre therapy, one-year and 10 years
Secondary Outcomes (11)
Emotional psychological processes
Once every week for the 12 weeks of active psychotherapy
cognitive psychological processes
Once every week for the 12 weeks of active psychotherapy
metacognitive psychological processes
Once every week for the 12 weeks of active psychotherapy
Common factors-alliance
Once every week for the 12 weeks of active psychotherapy
Common factors-expectations
Once every week for the 12 weeks of active psychotherapy
- +6 more secondary outcomes
Study Arms (2)
Inpatient treatment
ACTIVE COMPARATORHigh intensity high dosage inpatient short-term psychodynamic psychotherapy
Outpatient treatment
EXPERIMENTALLow dosage outpatient short-term psychodynamic psychotherapy
Interventions
Eligibility Criteria
You may not qualify if:
- current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Modum Badlead
Study Sites (1)
Modum Bad
Vikersund, Buskerud, 3370, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pål Ulvenes, PhD
Modum Bad
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2017
First Posted
June 3, 2021
Study Start
January 1, 2016
Primary Completion
December 1, 2021
Study Completion (Estimated)
December 1, 2026
Last Updated
June 3, 2021
Record last verified: 2021-05